U.S. patent application number 14/913808 was filed with the patent office on 2016-08-25 for method and apparatus for monitoring, documenting and assisting with the manual compounding of medications.
The applicant listed for this patent is EQUASHIELD MEDICAL LTD.. Invention is credited to Gonen DASKAL, Marino KRIHELI, Eric SHEM-TOV.
Application Number | 20160247277 14/913808 |
Document ID | / |
Family ID | 52593221 |
Filed Date | 2016-08-25 |
United States Patent
Application |
20160247277 |
Kind Code |
A1 |
KRIHELI; Marino ; et
al. |
August 25, 2016 |
METHOD AND APPARATUS FOR MONITORING, DOCUMENTING AND ASSISTING WITH
THE MANUAL COMPOUNDING OF MEDICATIONS
Abstract
The invention is a method and system for monitoring, documenting
and assisting with the manual preparation and/or administration of
medications. The invention accomplishes these goals via constant
surveillance of the preparation/administration process using one or
more digital cameras and software and hardware that processes the
images and compares data from the processed images with information
relative to the patient, to the drug components and composition of
the medicament, and to non-drug items needed in the preparation
that the system automatically or manually retrieves from various
sources, e.g. internal or external data banks, from the
technician/pharmacist, or by scanning the prescription.
Inventors: |
KRIHELI; Marino; (Tel Aviv,
IL) ; SHEM-TOV; Eric; (Ramat Hasharon, IL) ;
DASKAL; Gonen; (Kfar Hanasi, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EQUASHIELD MEDICAL LTD. |
Tefen Industrial Park |
|
IL |
|
|
Family ID: |
52593221 |
Appl. No.: |
14/913808 |
Filed: |
August 24, 2014 |
PCT Filed: |
August 24, 2014 |
PCT NO: |
PCT/IL2014/050755 |
371 Date: |
February 23, 2016 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G06T 7/62 20170101; G06K
9/18 20130101; G08B 21/18 20130101; G06K 9/00973 20130101; G06F
19/00 20130101; G06F 19/3456 20130101; G06Q 50/22 20130101; H04N
7/18 20130101; G06F 16/583 20190101; G07F 17/0092 20130101; B65B
55/02 20130101; G06T 2207/30232 20130101; G16H 20/10 20180101; G06F
16/252 20190101; G06T 7/0012 20130101; G16H 40/63 20180101; G06Q
10/06316 20130101; B65B 55/027 20130101; G16H 20/17 20180101; G06K
9/00771 20130101; B65B 3/003 20130101 |
International
Class: |
G06T 7/00 20060101
G06T007/00; H04N 7/18 20060101 H04N007/18; G06K 9/18 20060101
G06K009/18; G06Q 50/22 20060101 G06Q050/22; G08B 21/18 20060101
G08B021/18; G06F 17/30 20060101 G06F017/30; G06F 19/00 20060101
G06F019/00; G06Q 10/06 20060101 G06Q010/06; G06K 9/00 20060101
G06K009/00; G06T 7/60 20060101 G06T007/60 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 26, 2013 |
IL |
228122 |
Claims
1. A method for monitoring, documenting and assisting with the
manual preparation and/or administration of medications, said
method comprising: a) using at least one digital camera to provide
constant surveillance of the preparation/administration process; b)
providing software adapted to perform image processing of images
acquired by said at least one digital camera and to compare, in
real time, data extracted from the processed images to information
relative to one or more of a patient, drug components and
composition of said medication, and non-drug items needed in the
preparation, wherein said data is automatically or manually
retrieved from various sources; and c) providing dedicated software
algorithms that are adapted to act as an interactive assistant
guiding and/or supervising a producer through each step of a
specific preparation process
2. The method of claim 1, comprising providing software adapted to
compile complete documentation of the medication preparation
process in the form of visual and data archives of the preparation
steps, in which every step in the preparation process is documented
and indexed.
3. The method of claim 1, comprising a stage comprised of general
steps that are followed for filling any type of prescription;
wherein the algorithms in the software are adapted to verify the
correct match of a prescription to a patient and to his/her medical
condition and to supervise or guide a producer when selecting the
prescribed drugs and equipment needed for the preparation
process.
4. The method of claim 1, wherein a visual or aural warning alerts
the producer, if an error is detected at any stage of the
preparation or administration process.
5. The method of claim 3, wherein the images and data that are
processed by the software are saved together with the parameters of
the objects visible in said images that the software has deduced
for them.
6. The method of claim 1, wherein barcode recognition, QR code
recognition, OCR (Optical Character Recognition), and additional
pattern recognition algorithms are used to supply data from the
images.
7. The method of claim 1, wherein images of a syringe are analyzed
to determine at least one of the following: a) the type and size of
said syringe; b) whether said syringe is filled with air or
transparent liquid; c) whether bubbles are present in the liquid in
said syringe; d) to determine the volume of said bubbles; and e) to
measure the volume of liquid in said syringe by recognizing the
piston of said syringe and a reference line on the barrel of said
syringe and measuring the distance between them.
8. A system for monitoring, documenting and assisting with the
manual preparation and/or administration of medications, said
system comprising: a) at least one digital camera adapted to
provide constant surveillance of the preparation/administration
process; b) a processor unit comprising: i) software adapted to
perform image processing of images acquired by said at least one
digital camera and to compare, in real time, data extracted from
the processed images to information relative to one or more of a
patient, drug components and composition of said medication, and
non-drug items needed in the preparation, wherein said data is
automatically or manually retrieved from various sources; ii)
dedicated software algorithms that are adapted to act as an
interactive assistant guiding and/or supervising a producer through
each step of a specific preparation process; and c) a display
screen adapted to serve as an interface between said producer and
the software of said system.
9. The system of claim 8, wherein the processor unit additionally
comprises software adapted to compile complete documentation of the
medication preparation process in the form of visual and data
archives of the preparation steps, in which every step in the
preparation process is documented and indexed.
10. The system of claim 8, adapted to produce a visual or aural
warning to alert the producer if an error is detected at any stage
of the preparation or administration process.
11. The system of claim 8, wherein the image processing software is
adapted to use barcode recognition, QR code recognition, OCR
(Optical Character Recognition), and additional pattern recognition
algorithms to supply data from the images.
12. The system of claim 8, wherein the image processing software is
adapted to process images of a syringe taken by the at least one
digital camera in order to determine at least one of the following:
a) the type and size of said syringe; b) whether said syringe is
filled with air or transparent liquid; c) whether bubbles are
present in the liquid in said syringe; d) to determine the volume
of said bubbles; and e) to measure the volume of liquid in said
syringe by recognizing the piston of said syringe and a reference
line on the barrel of said syringe and measuring the distance
between them.
13. The system of claim 12, comprising an illuminated surface on
which a syringe can be placed.
14. The system of claim 13, wherein the source of illumination is
polarized.
15. The system of claim 8, wherein said system is adapted to be
portable.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to the field of administering
drugs and medications to patients. More particularly, the present
invention relates to the field of monitoring, preparation, and the
manual compounding of medication.
BACKGROUND OF THE INVENTION
[0002] In the preparation and administration of different
medications, medical personal are required to make sure that only
the correct drugs, accurate dosages, and proper equipment is used.
In the simplest case all that is required is that the producer,
e.g. a pharmacist or a pharmacy tech, use a syringe to withdraw the
required volume of a drug in liquid form from a vial or capsule in
which it has been packaged by the manufacturer and then to transfer
the syringe to a doctor or nurse to inject the withdrawn volume of
drug directly into a vein of the patient or into an infusion bag.
In a more complex procedure the drug may come in powdered form
contained within a vial and must be reconstituted by injecting a
suitable diluent, e.g. distilled and/or deionized water or saline
solution into the vial with a syringe, thoroughly mixed, and then
the required dosage withdrawn using the same in a different
syringe.
[0003] In hospital settings each patient may receive medication in
many forms, e.g.
[0004] pills, injections, and IV drips. Each patient receives his
own individual prescription according to a schedule determined by
his doctor. Depending on the hospital's procedures, a pharmacist or
a pharmacy-technician is responsible for preparing the prescribed
medication, including compounding medications by combining and/or
processing appropriate ingredient(s) utilizing various pieces of
medical equipment, properly labeling the medication for each
patient, and providing it to a nurse for administration.
[0005] Amongst the more complex and potentially dangerous
procedures carried out in hospital pharmacies is the compounding of
"cocktails" for treatment of diseases such as AIDS and cancer.
Because of the hazardous nature of the drugs that make up the
cocktail, the complexity of their preparation, the accurate dosage
required, the frequency by with they are administered to the
patient, and the physical condition of the patient, a great deal of
skill and attention to detail is required in their preparation.
Chemotherapeutic agents are usually prescribed by a medical
oncologist or a hematologist. A chemotherapy regimen (schedule)
typically consists of a specific number of cycles given over a set
period of time. A patient may receive one drug at a time or
combinations of different drugs at the same time. After the
chemotherapeutic agent is prepared for the patient, the patient
receives the medication, which can be administered intravenously,
orally, as an injection to the fatty part of the arm, leg, or
abdomen, intra arterially, intraperitoneally, or topically.
[0006] Obviously the consequences to the patient, of errors in
compounding the drugs, can be very severe; however, also contact
with the drugs or their vapors can be potentially very hazardous to
the personal that prepare the medicaments and administer them as
well. Therefore proper protocols must also be followed "to the
letter" to avoid errors and accidents.
[0007] To prevent, or at least to minimize, the number of mistakes
many methods and systems, including computerized systems, which
monitor the work of the pharmacist/pharmacy-technician, and alert
when a mistake occurs, have been devised.
[0008] An example of a prior art system with an automated machine
for preparation of pharmaceutical products is disclosed in U.S.
Pat. No. 8,297,320. This patent describes an apparatus contained
within a box-type holding frame, which defines a chamber. The
apparatus is comprised of a gripping and carrier mechanism to
transfer a container between a magazine containing a plurality of
containers, e.g. syringes, and a dosage station comprising a flat
turntable, adapted to receive and hold three syringes having
different diameters and lengths, where the pharmaceutical product
is prepared. The chamber has an access aperture to the magazine. A
pneumatic device, with a fan wheel to assure air circulation, is
adapted to supply a sterile air flow through the entire chamber and
to prevent the exchange of air with the outside environment.
[0009] It is a purpose of the present invention to provide a
complete system for guiding, monitoring, and documenting the
process of preparation of medication for administration to
patients.
[0010] Further purposes and advantages of this invention will
appear as the description proceeds.
SUMMARY OF THE INVENTION
[0011] In a first aspect the invention is a method for monitoring,
documenting and assisting with the manual preparation and/or
administration of medications. The method comprises the steps of:
[0012] a) using at least one digital camera to provide constant
surveillance of the preparation/administration process; [0013] b)
providing software adapted to perform image processing of images
acquired by the at least one digital camera and to compare, in real
time, data extracted from the processed images to one or more of
information relative to a patient, drug components and composition
of the medication, and non-drug items needed in the preparation,
wherein the data is automatically or manually retrieved from
various sources; and [0014] c) providing dedicated software
algorithms that are adapted to act as an interactive assistant
guiding and/or supervising a producer through each step of a
specific preparation process
[0015] Embodiments of the method of the invention comprise
providing software adapted to compile complete documentation of the
medication preparation process in the form of visual and data
archives of the preparation steps, in which every step in the
preparation process is documented and indexed.
[0016] Embodiments of the method of the invention comprise a stage
comprised of general steps that are followed for filling any type
of prescription. In this stage the algorithms in the software are
adapted to verify the correct match of a prescription to a patient
and to his/her medical condition and to supervise or guide a
producer when selecting the prescribed drugs and equipment needed
for the preparation process.
[0017] Embodiments of the method of the invention comprise a visual
or aural warning to alert the producer if an error is detected at
any stage of the preparation or administration process.
[0018] In embodiments of the method of the invention the images and
data that are processed by the software are saved together with the
parameters that the software has deduced for the objects visible in
the images.
[0019] In embodiments of the method of the invention barcode
recognition, QR code recognition, OCR (Optical Character
Recognition), and additional pattern recognition algorithms are
used to supply data from the images.
[0020] In embodiments of the method of the invention images of a
syringe are analyzed to determine at least one of the following:
[0021] a) the type and size of the syringe; [0022] b) whether the
syringe is filled with air or transparent liquid; [0023] c) whether
bubbles are present in the liquid in the syringe; [0024] d) to
determine the volume of the bubbles; and [0025] e) to measure the
volume of liquid in the syringe by recognizing the piston of the
syringe and a reference line on the barrel of the syringe and
measuring the distance between them.
[0026] In a second aspect the invention is a system for monitoring,
documenting and assisting with the manual preparation and/or
administration of medications. The system comprises: [0027] a) at
least one digital camera adapted to provide constant surveillance
of the preparation/administration process; [0028] b) a processor
unit oomprioing: [0029] i) software adapted to perform image
processing of images acquired by the at least one digital camera
and to compare, in real time, data extracted from the processed
images to information relative to one or more of a patient, drug
components and the composition of the medication, and non-drug
items needed in the preparation, wherein the data is automatically
or manually retrieved from various sources; [0030] ii) dedicated
software algorithms that are adapted to act as an interactive
assistant guiding and/or supervising a producer through each step
of a specific preparation process; and [0031] c) a display screen
adapted to serve as an interface between the producer and the
software of the system.
[0032] In embodiments of the system of the invention the processor
unit additionally comprises software adapted to compile complete
documentation of the medication preparation process in the form of
visual and data archives of the preparation steps, in which every
step in the preparation process is documented and indexed.
[0033] Embodiments of the system of the invention are adapted to
produce a visual or aural warning to alert the producer if an error
is detected at any stage of the preparation or administration
process.
[0034] In embodiments of the system of the invention the image
processing software is adapted to use barcode recognition, QR code
recognition, OCR (Optical Character Recognition), and additional
pattern recognition algorithms to supply data from the images.
[0035] In embodiments of the system of the invention the image
processing software is adapted to process images of a syringe taken
by the at least one digital camera in order to determine at least
one of the following: [0036] a) the type and size of the syringe;
[0037] b) whether the syringe is filled with air or transparent
liquid; [0038] c) whether bubbles are present in the liquid in the
syringe; [0039] d) to determine the volume of the hubbies; and
[0040] e) to measure the volume of liquid in the syringe by
recognizing the piston of the syringe and a reference line on the
barrel of the syringe and measuring the distance between them.
[0041] Embodiments of the system of the invention comprise an
illuminated surface on which a syringe can be placed. In these
embodiments of the system of the invention the source of
illumination can be polarized.
[0042] Embodiments of the system of the invention are adapted to be
portable.
[0043] All the above and other characteristics and advantages of
the invention will be further understood through the following
illustrative and non-limitative description of embodiments thereof,
with reference to the appended drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] FIG. 1 schematically illustrates an example for a work-space
for compounding medications;
[0045] FIG. 2 is a flow chart that schematically shows the steps in
the first stage of the process of the invention;
[0046] FIG. 3 is a flow chart that schematically illustrates the
second stage of a simple process of filling a prescription; and
[0047] FIG. 4A and FIG. 4B are two parts of a flow chart that
schematically illustrates the second stage of a much more complex
compounding procedure.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0048] The invention is a method and system for monitoring,
documenting and assisting with the manual preparation and/or
administration of medications. The invention accomplishes these
goals via constant surveillance of the preparation/administration
process using one or more digital cameras and software and hardware
that processes the images and compares data from the processed
images with information relative to the patient, to the drug
components and composition of the medicament, and to non-drug items
needed in the preparation that the system automatically or manually
retrieves from various sources, e.g. internal or external data
banks, from the technician/pharmacist, or by scanning the
prescription.
[0049] The invention is based on image processing, and the
monitoring of the preparation process is done using image
processing technology. Complete documentation of the medication
preparation process is based on a visual archive of the preparation
steps, in which every step in the preparation process is documented
and indexed in various ways, e.g. by the patient's or pharmacist's
or doctor's identity or by date, and initially stored in a local
memory unit that is a part of the processor of the system. For
example, the documentation is stored in the pharmacy until the
patient is released from the hospital and then sent by wireless or
wired technology to be archived in a remote data memory unit. The
saved data/documentation can comprise such information as: time
stamps; details of prescriptions; patient identification and
information, e.g. sex, age, weight, height, disease being treated;
preparation phase details, e.g. comments, confirmations, alerts;
log messages, e.g. errors, warnings, trace, debug; identification
and verification of supervisor's permission if required; details of
the technician that prepared the prescription and the supervisor; a
visual archive of images taken during the preparation phase; and
information regarding the dispensing phase.
[0050] The system of the invention comprises an internal database
that is updated manually, according to the hospital guidelines, by
an administrator and/or automatically from the hospital's
databases. In embodiments of the invention the system can be
connected to external databases of other hospitals, health
institutes (e.g. FDA=Food and Drug Administration and NIH=National
Institute of Health) and manufacturers, via a communication
network.
[0051] Typical of the wide variety of information that can be
included in the database and used by the algorithms in the software
of the invention is: [0052] a) Packaging dosage, physical
properties, reconstitution, dilution dosages and dispensing
instructions etc. of drugs. The information can be continuously
updated, either automatically or manually, with information from
sources such as the FDA, NIH and medicines companies. [0053] b)
Capacity, catalog numbers, National Drug Code (NDC) numbers,
barcodes, or other identifying features of IV Bags. The information
is continuously updated, either automatically or manually, with
information from the FDA, NIH and producer companies. [0054] c)
Capacity, catalog numbers, dimensions or other identifying features
of syringes and adaptors. The information is continuously updated,
either automatically or manually, from sources such as catalogues
of medical products manufactures and distributers. [0055] d) Images
and video streams, both raw and processed taken by the system
camera/s.
[0056] In one embodiment of the system, the system automatically
compares dosages and diluents on the prescription to data in the
drug manuals, or other data inserted into the system's database and
verifies that the prescribed doses comply with the recommended dose
tolerances in order to avoid errors and resulting wrong dosages. In
case of differences between the prescribed and recommended doses
the system sends an alert via the interface to the producer, i.e.
the pharmacist, pharmacist technician or other person using the
system of the invention, and optionally to the prescribing doctor
or other hospital personnel.
[0057] In one embodiment, the invention is a workflow driven system
with a software automation tool based on a physician defined
prescription that acts as an interactive assistant guiding the
producer (pharmacist or pharmacist tech) through the production
process. The system of the invention is designed to guide, monitor
and document every step of the manual preparation, including
compounding, of the medication. In case an error is detected, a
visual or aural warning is produced by the system to alert the
producer. All steps of the preparation process are recorded and
stored in memory for later reference.
[0058] FIG. 1 schematically illustrates a work-space for filling
prescriptions or compounding medications according to the
invention. The hardware components of the system of the invention
that are shown in FIG. 1 include: one or more digital cameras (30)
which are located above the work-space table, next to the table or
attached to the body of the producer and have a field of view large
enough to cover the areas of interest; a display screen (31)
serving as the interface between the producer and the system; and
the work surface (32) itself. The screen can be part of a
processor, i.e. a single unit, or communicate with it by means of
wired or wireless technology (not shown). The processor could be,
for example, a PC or mobile device such as a cellular phone or
notepad. The processor comprises dedicated software for processing
and interpreting images received from the camera or cameras 30;
communication means for connecting to external databases and memory
units for storing images and data collected during the process of
filling the prescription, e.g. via the internet or the hospital's
local area network;
[0059] optional internal databases and memory units for temporary
or permanent storage of at least some of the data used and
collected; and dedicated software comprising algorithms adapted to
guide and supervise the producer. In embodiments of the system of
the invention the system may further comprise other equipment, e.g.
a label printer, a label dispenser, and/or a sterilizer unit (not
shown). Also shown in FIG. 1 are examples of some of the items
typically involved in the compounding of medicaments. These items
include: an IV bag (33), a syringe (34), and a drug vial (35).
[0060] Embodiments of the invention employ two types of camera:
[0061] 1) High resolution cameras are used for the supervision of
the drug dispensing process. These cameras can be either still or
video cameras. The still cameras can be triggered by several
different means, e.g. foot pedal, voice command, pressing an icon
on the display screen, light change, distance from a vicinity
sensor. The video cameras will send images to the vision processing
algorithm. When the algorithm recognizes an interpretable image it
will process it and send feedback to the operator of the
system.
[0062] 2) Wide field of view video cameras that cover the entire
working area. The files from this camera will be used for
documentation only.
[0063] There are two methods in which the system can be
implemented. In the first method, which is a "Free Style" method,
the video cameras cover the entire working area and the technician
works freely, independently of the operation of the camera. In this
method the entire video sequence and/or only selected frames that
show specific stages in the preparation procedure will be stored in
a database for future documentation. In the second method the
producer should place the equipment, e.g. a vial, syringe, or bag,
at a specific location in the field of view of the still or video
cameras, which are then activated by the producer or by the
software to capture and process an image.
[0064] The images that are processed by the software will be saved
with the parameters that the software deduced for the objects
visible in the images, i.e. syringe volume, NDC numbers, drug name
etc. The identification of the items employed in the medication
preparation process is carried out automatically by the algorithms
of the software in the processor, which compares the processed
images with information drawn from the databases. The software is
adapted to use barcode recognition, QR code (Quick Response Code),
OCR (Optical Character Recognition), and additional pattern
recognition algorithms to deduce and interpret the following data
from the images:
[0065] 1) Syringe: [0066] a. Syringe size (e.g. 20 cc, 30 cc, 60
cc) by recognizing code or writing on the label, or by measuring
the syringe and comparing the measurements to values in the
system's database. [0067] b. Syringe brand by recognizing code or
writing on the label, or by measuring the syringe and comparing the
measurements to values in the system's database. [0068] c. Volume
of drug in the syringe by recognizing the position of the piston
compared to the graduation marks on the syringe or by measuring the
distance between the syringe piston and a mark on the barrel or the
end of the syringe barrel, and calculating the volume from the
geometry of the syringe or by interpolation according to data in
the systems database. [0069] d. Syringe ID. In an embodiment of the
system, the syringe is labeled for use in the system. Each syringe
is given an In, e.g. barcode, other characters, or color. This
label will be recognized in images of the syringe and read by the
software using OCR or other means. e. The existence of a bubble in
the liquid in the syringe and an estimation of its size by pattern
recognition.
[0070] 2) Drug and Bottle (vial); [0071] a. Vial size by geometry
interpretation and label reading. [0072] b. Drug information, e.g.:
type (generic name); volume; state (powder or liquid);
concentration; special characteristics, e.g. sensitivity to light
and need to filter; recommended dose; and recommended diluents. The
information is obtained by using OCR to recognize the NDC or
commercial name on the bottle and comparing the information with
system's database. [0073] c. Drug expiration date and lot number by
OCR from a label on the drug container. [0074] d. Manufacturer's
#LOT number by means of OCR
[0075] 3) Infusion bag: bag material, liquid type, volume,
expiration date, lot number, by reading a barcode or QR code
recognition and/or NDC number by OCR.
[0076] 4) Details of the prescription as it appears on a sticker
that is either attached to an infusion bag or other object or is
scanned alone before being attached to an object, e.g. a syringe,
by means of character recognition (OCR) of the printing on the
sticker.
[0077] The use of digital cameras gives the system of the invention
flexibility to interpret patterns, characters, barcode, and QR code
using just one type of sensor (i.e. the camera). This is in
contrast to, for example, laser scanners that might recognize
barcodes and the outlines of an object, but not characters or
patterns that might appear within an object, for example the
position of the syringe piston within the syringe barrel.
[0078] The current state of the art for drug preparation control is
based on the use of a weighing scale. This method allows a very
accurate control of the weight of the drug and infusion liquids,
which can be directly converted into volumes; but it doesn't allow
the evaluation of any information that is not weighable like: drug
type, infusion liquid type, lot numbers, expiry dates and bubble
recognition. Another advantage of the use of camera compared with
the weighing method is the flexibility and the ease of the use of
the system. At no stage, does the producer need to stop his flow of
work, or place the objects on a scale without touching them, and to
wait for the scale to stabilize before taking a reading. All that
the producer needs to do is to present the object, e.g. drug vial,
syringe, label, IV bag, to the camera at specific times.
[0079] The algorithms in the software of the processor of the
system of the invention may be adapted to act as an interactive
assistant guiding the producer through the preparation process.
This process includes choosing the correct drugs and equipment for
the preparation according to the prescription and, optionally,
verifying the correct match of the prescription to the patient by
comparing the prescription to the patient's medical history.
[0080] The method of the invention can be carried out in many
different ways, representative examples of which are described in
the following examples. It is to be understood that many other
scenarios are possible and that some of the steps may be
eliminated, others added, and the order of the steps may be changed
depending on the exact nature of the prescription to be filled
and/or the drugs to be compounded.
[0081] An embodiment of the method of the invention is comprised of
two stages. The first stage, which is illustrated in FIG. 2,
comprises general steps that are followed for filling any type of
prescription. In this stage the algorithms in the software of the
invention are adapted to verify the correct match of the
prescription to the patient and his/her medical condition and to
supervise or guide the producer when selecting the correct drugs
and equipment for the preparation. In the second stage the
algorithms in the software of the system of the invention are
adapted to act as an interactive assistant guiding and supervising
the producer through the preparation process. The exact steps of
the second stage of the process are very specific to the
prescription being filled. Some typical examples will be described
in FIGS. 3, 4A, and 4B.
[0082] FIG. 2 is a flow chart that schematically shows the steps in
the first stage of the process of the invention. The process shown
is only meant to illustrate the capabilities of the system of the
invention. In practice the first stage can be carried out exactly
as described or in many different variations in which the order in
which the steps are carried out is changed and/or some of the steps
are not carried out at all.
[0083] This stage of the process is initiated (101) when an image
of a label containing the prescription to be filled is taken by one
of the cameras of the system and the information on the label is
read using the OCR software in the system processor. The label is
made out according to the instructions of the physician and, in
addition to personal identifying information of the patient,
comprises all information needed by the producer in order to
prepare the drug for administration to the patient. The
prescription label is typically attached to the means, e.g. IV bag
or syringe, with which the prepared drug is to be administered to
the patient. Examples of the information on the prescription label
are the generic and brand names of the drug to be administered,
method of administration, e.g. IV drip or injection, type of
diluent, and calculated dilution rate. The prescription read from
the image is compared with that in the hospital data network in
order to insure that the producer will be working on the correct
prescription and also to be certain that the UCH software has
accurately read the writing on the label.
[0084] In an embodiment of the invention, the system is adapted to
manage the preparation flow in the pharmacy and to divide the
different preparations between more than one producer. This option
is useful because in most hospital pharmacies there is a constant
flow of prescriptions that need to be prepared coming from the
hospital's data network. Some of these prescriptions will be urgent
while others might need to be canceled or delayed (for example,
because the patient's condition suddenly deteriorates while waiting
for the treatment),
[0085] In embodiments of the system of the invention, a display
screen is located outside the preparation room, for example in the
pharmacy office, or in a hospital administrator's or manager's
office. This screen can be a split screen that will show videos
from every cabinet in which the system is installed or can display
the actual screen images from the GUI of each of the producers that
are working with the system at any given time.
[0086] In step 101 the system also verifies that the correct IV bag
or syringe for administration of the drug to the patient has been
selected. In this step the system also verifies drug exceptions,
i.e. if the drug requires handling with non PVC equipment, light or
sunlight protection, etc. In step 102, the algorithm in the system
processor reads the patient's medical history from the hospital
data base and consults its internal data base, which is constantly
updated with the latest information from external data bases, e.g.
those of the hospital, national ministry of health, drug and
medical equipment manufacturers, the FDA or NIH, to determine if
the prescribed drug or combination of drugs is suitable for the
patient's condition. If the answer is `no` then the system either
prompts the producer to contact the prescribing physician or does
so directly, e.g. by email or SMS, to verify his instructions. If
the answer is `yes`, then the process proceeds to step 103. In this
step the system, via the display screen 31 prompts the producer to
obtain containers containing drugs having the prescribed active
ingredients and diluents from the pharmacy storage units. The
producer obtains the recommended drug containers and places them on
the working surface 32. In step 105, images of the drug containers
are recorded by the system and the image processing software
generates identifying data, e.g. from the printing on the label,
bar code, color of the contents, NDC number, etc. that is compared
in step 106 with similar data in the internal database of the
system and the prescription just read, to verify that the correct
drug and volume of drug in the container has been placed on the
work surface. If, in step 106, an error is detected, then an
audible or visual (or both) alarm is generated by the system. In
this step as in all other image gathering steps of the procedure,
if the system is unable to image sufficient identifying data, it
may prompt the producer to move or rotate the drug container. If
moving or rotating the drug container doesn't remove the source of
the error, then the process returns to step 104, or the system can
allow the producer, or his supervisor, to insert the data manually.
For that purpose special authorization will be needed, e.g. a
password or a magnetic card. If no error is detected, then the
process proceeds to step 107 in which the producer is prompted to
select the non-drug items that are needed to prepare the medication
called for in the prescription, e.g. syringes of a certain size and
container with the required diluent if a reconstitution process is
required. In step 108, images of the items on the workplace are
recorded by the system and, in step 109, the image processing
software compares identifying features of the items, e.g.
manufactures catalogue numbers, volume scales printed on the item,
with similar features from a the internal database of the system
and determines whether the correct items have been selected when
compared to the prescription. If in step 109 an error is detected
then an audible or visual alarm (or both) is generated by the
system and the process returns to step 107. If no error is
detected, then the process proceeds to stage 2.
[0087] It is again emphasized that FIG. 2 shows many steps that are
optional and that in different embodiments the algorithms in
software of the processor of the system of the invention can be
configured to function with or without these features. For example,
in some embodiments steps 102 and 103 are not executed and the
algorithms assume that the prescription, as written by the
physician and read in step 101, is correct. As another example, in
step 107 the system may not be adapted to determine which non-drug
components are necessary to prepare the medication. The producer
may choose the components on the basis of his knowledge and
experience or with reference to professional literature or
specialized databases.
[0088] It is noted that the second stage, examples of which will be
described herein below, can be carried out independently of the
first stage and in some embodiments of the method the first stage
is not carried out at all.
[0089] FIG. 3 is a flow chart that schematically illustrates stage
2 of a simple process of filling a prescription, which calls for
the administration of two pills to lower the blood pressure and an
anti-depressant capsule to a patient. Despite the apparent
simplicity of the procedure, all steps of the first stage are
followed. These drugs are normally supplied in packaging, e.g.
bottles, containing relatively large quantities of the drug,
therefore, in step 201 the producers removes the required number of
pills from each package and lays them on the work surface. In step
202 images of the work surface are scanned and the image processing
software identifies characteristics of the pills such as color,
shape, and identifying marks. In step 203 the features identified
from the scans are compared with information from a database, such
as that of the drug manufacturer. This step is carried out to
confirm that the containes have not been mislabeled or that pills
have not been inadvertently returned to the wrong bottle in an
earlier preparation procedure. If the system cannot verify that the
correct pills have been selected, an alarm is generated and the
process returns to step 201. If the system verifies that the
correct pills have been selected the process continues to step 204.
In step 204 the software analyzes the images to determine if the
correct number of pills of each type has been removed from the
containers. If the answer is `no`, the process is returned to step
201. If the answer is `yes`, then the pills are placed in a
container, e.g. a paper cup, that has been placed on the work
surface in step 107 of the first stage. In step 206 a label on
which is written information, such as the ward and room number of
the patient, his name and identity number, and other information
such as the date and time the medication was prepared and by whom,
when the medication is to be administered, the prescribing
physician, etc. is created and placed on the container containing
the pills. It is noted that step 206 can be carried out as shown or
earlier, for example after step 109 or after step 204. Finally, in
step 207, the labeled container is placed on a drug cart to be
delivered to the staff member responsible for administering it to
the patient.
[0090] FIG. 4A and FIG. 4B are two parts of a flow chart that
schematically illustrates stage two of a much more complex
compounding procedure. In this example the prescription calls for
administering a medication comprised of two drugs to a patient by
means of an IV drip. Drug A is supplied as 2 grams of dry powder in
a 20 ml glass vial and drug B is supplied as a liquid in a 20 ml
glass vial. The prescription calls for 1 gram of reconstituted drug
A and 10 ml of drug B added to an infusion bag to which the
prescription label (see step 101) is attached.
[0091] In step 301, the producer is prompted to place drug A in the
field of view of one of the cameras of the system, which images the
vial containing drug A. The software in the processor analyzes the
images to determine if the drug matches that called for in the
prescription. If the answer is no, an alarm is generated and the
producer must locate the correct drug bottle. If the answer is yes,
then the process proceeds to step 302.
[0092] In step 302 images of the drug bottle are analyzed and the
NDC number or a barcode are read to determine if the drug has to be
reconstituted. Since the drug contained in the bottle may have been
previously reconstituted, e.g. is "left-over" from a previous
preparation, the system prompts the producer asking him to verify,
e.g. by pressing an icon on a display screen, that a reconstitution
process has to be carried out. If the answer is no, then the
process skips ahead to step 308. If the answer is yes, then the
process continues to step 303.
[0093] In step 303 the system instructs the producer to select a
particular diluent. The container, e.g. an IV bag that contains the
diluent, is imaged by the system camera and the algorithm in the
software reads information on the container and compares the result
with the database to determine if the correct diluent has been
selected. If the answer is no, an alarm is generated and the system
prompts the producer to select a different diluent. If the correct
diluent has been selected, then the process proceeds to step
304.
[0094] In step 304, the system prompts the producer to fill a
certain sized syringe with a specified volume of diluent. In step
305, the syringe is separated from the container with diluent and
images of the filled syringe are analyzed. The software algorithms
of the system search for bubbles in the liquid in the syringe and
also measure the volume and compare it with the volume that is
recommended in the system database. If bubbles are detected and/or
the volume of diluent is incorrect, then an alarm is generated and
the producer follows the known procedure to eliminate them and the
process returns to step 304 to adjust the volume of diluent in the
syringe. If there are no bubbles and the volume is correct then the
process proceeds to step 306.
[0095] In step 306, the system prompts the producer to connect the
syringe containing the diluent to the vial containing drug A and to
inject the diluent into the vial. In step 307, the syringe is
imaged while still connected to the vial and the images are
analyzed to confirm that the syringe is now empty, i.e. to confirm
that the required volume of diluent has been added to powdered drug
A inside the vial. In step 308, after thoroughly mixing the
contents of the vial, the producer is prompted to draw the required
volume of reconstituted drug A from the vial into a syringe.
[0096] In step 309, the syringe is separated from the vial
containing reconstituted drug A and images of the filled syringe
are analyzed. The software algorithms of the system search for
bubbles in the liquid in the syringe and also measure the volume
and compare it with the volume that is called for in the
prescription. If bubbles are detected and/or the volume of drug A
is incorrect, then an alarm is generated and the producer follows
the known procedure to eliminate the bubbles and the process
returns to step 308 to adjust the volume of drug A in the syringe.
If there are no bubbles and the volume is correct then the process
proceeds to step 310.
[0097] In step 310, the system prompts the producer to connect the
syringe containing reconstituted drug A to the IV bag that will be
administered to the patient and to inject drug A into the IV bag.
In step 311, the syringe is imaged while still connected to the IV
bag and the images are analyzed to confirm that the syringe is now
empty, i.e. to confirm that the required volume of drug A has been
added to the IV bag.
[0098] Preparation with drug A has now been completed. In step 312,
the producer is prompted to place drug B in the field of view of
one of the cameras of the system, which images the vial containing
drug B. The software in the processor analyzes the images to
determine if the drug matches that called for in the prescription.
If the answer is no, an alarm is generated and the producer must
locate the correct drug bottle. If the answer is yes, then the
process proceeds to step 313.
[0099] In step 313 images of the drug bottle are analyzed and the
NDC number or a barcode are read to determine if the drug has to be
reconstituted. Since drug B does not have to be reconstituted, the
process proceeds to step 314.
[0100] In step 314, the producer is prompted to draw the required
volume of drug B from the vial into a syringe.
[0101] In step 315, the syringe is separated from the vial
containing drug B and images of the filled syringe are analyzed.
The software algorithms of the system search for bubbles in the
liquid in the syringe and also measure the volume and compare it
with the volume that is called for in the prescription. It bubbles
are detected and/or the volume of drug B is incorrect, then an
alarm is generated and the producer follows the known procedure to
eliminate the bubbles and the process returns to step 314 to adjust
the volume of drug B in the syringe. If there are no bubbles and
the volume is correct then the process proceeds to step 316.
[0102] In step 316, the system prompts the producer to connect the
syringe containing drug B to the IV bag that will be administered
to the patient and to inject drug B into the IV bag. In step 317,
the syringe is imaged while still connected to the IV bag and the
images are analyzed to confirm that the syringe is now empty, i.e.
to confirm that the required volume of drug B has been added to the
IV bag.
[0103] Preparation with both drugs A and B has now been completed
(step 318). In step 319 a label with the word "DONE" or a similar
word or other data, printed on it is produced and affixed to the IV
bag containing drugs A and B. All relevant information including
the patient's name and contents of the IV bag are already present
on the prescription label that was attached to the bag in step
101.
[0104] Finally, in step 320, the producer is prompted how to
dispose of the unused materials, e.g. he is told if the volume of
drug B or reconstituted drug A remaining in the respective vials
can be returned to the storage unit and if so under what
conditions, e.g. refrigerated or at room temperature.
[0105] In all of the procedures for filling prescriptions,
especially when dealing with toxic drugs and those which are easily
detrimentally affected by contamination, the system, via the
display informs the producer of the correct procedures to maintain
sterility and safety.
[0106] In addition to being set up in hospital pharmacies as
described herein above, portable embodiments of the system can be
provided, for example on the carts used to dispense medication to
patients in the hospital wards. With the exception of the work
surface, the rest of the system can be provided as a hand-held unit
comprising a still or video camera, a display screen, and
processing unit. The hand-held system can be embodied either as a
dedicated unit or as an application to a cellular phone. In this
embodiment the camera can be used to verify the identity of the
patient by imaging the medical chart attached to his/her bed or the
patient's wrist band.
[0107] Embodiments of the invention can comprise facial recognition
software to accomplish this step. Once the identity of the patient
has been confirmed, the person administering the medication places
the container prepared for the patient on the top of the cart.
Images of the label on the container, e.g. syringe, IV bag, cup
containing pills, are taken with the camera and analyzed to verify
that the patient receives the medication prescribed for him/her by
the physician. The camera can continue to take images of the
administration process to provide documentation that the medication
has been properly administered.
[0108] In working with syringes one common problem is the presence
of air bubbles together with the liquid that is drawn into the
barrel of the syringe. Air bubbles affect the accuracy of the
dosage and, if injected into a blood vessel of the patient, can
cause serious and sometimes fatal complications. Because of the
difference in the optical properties there is a visually notable
difference between air and the liquid in the syringe. The image
processing algorithms are able to identify this difference and thus
the presence of bubbles in the images of the filled syringe and to
generate a warning to the producer or administrator of the
medication (see steps 305, 309, and 315 in FIGS. 4A and 4B). One
method of identifying the presence of the bubbles that has been
employed in embodiments of the system of the invention--both in the
pharmacy and in portable units--is to incline at least a portion of
the work surface at an angle, e.g. 5-90 degrees with a horizontal
plane. After being tilled with liquid, the syringe is placed on
this surface tip up with its longitudinal axis aligned with the
slope of the surface. In this configuration the bubble (or bubbles)
rises to the top of the liquid and the image processing algorithm
can easily identify the bubble and/or measure its actual volume.
The algorithm, simultaneously, measures the volume of the liquid
drawn to the syringe barrel by `counting` the marks printed on the
wall of the syringe by the manufacturer or by measuring the
distance between the syringe piston and the end of its barrel, and
calculating the volume by multiplying this distance with the
barrels inner diameter, taken from the system's database. Then the
algorithm will approve the volume or warn for bubble existence and
calculate the actual liquid volume by subtracting the bubble volume
from the liquid volume. An alternate method of assisting the
software of the system to identify the presence of bubbles in the
syringe would be to place the syringe on an illuminated surface or
on a transparent surface and to provide a source of illumination
under the surface. In this embodiment the incident angle of the
light with respect to the syringe might be less than the critical
angle of the liquid in the syringe and the light might be polarized
to cause optical effects that increase the visibility of the
bubbles. In another embodiment the syringe can be held at an angle
with the horizontal and the volume of the bubble and/or the liquid
in the syringe can be determined from the camera images.
[0109] Embodiments of the system of the invention comprise a label
printer, which is connected to the system by a wire or wireless
communication connection. The label printer finalizes the
preparation process for a specific patient. After the preparation
process is finished (step 319 in FIG. 4B) a label is printed from
the label printer and attached to the IV bag or syringe (IV push),
or other container that contains the medicine, which is to be
administered to the patient. The labels are clearly marked with
information that signifies that the medicine is ready for
administration to the patient, e.g. the word "DONE" or "READY" and
can be printed with information that can include, for example, the
time stamp of preparation and administration; names of the
producer;, a logo for the system and/or a code that can be matched
to the data about the specific preparation, as stored in the
system's database. Instead of a printed label an electronic label,
e.g. a RFID chip, can be produced and attached to the IV bag or
syringe.
[0110] Embodiments of the system of the invention may also include
other components, for example a UV, ozone, alcohol, or chloroform
sterilization unit. The algorithm of the software in the processor
of the system are adapted to prompt the user regarding which items
involved in the preparation process require sterilization in this
unit, at what stage in the preparation process the items should be
placed in the unit, and to control the operation of the unit to
achieve optimal results.
[0111] Although embodiments of the invention have been described by
way of illustration, it will be understood that the invention may
be carried out with many variations, modifications, and
adaptations, without exceeding the scope of the claims.
* * * * *